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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03665987
Other study ID # B2018-112R
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 1, 2018
Est. completion date June 30, 2022

Study information

Verified date September 2018
Source Shanghai Zhongshan Hospital
Contact Fang Fang, Doctor
Phone 86-13681972715
Email jerryfang81@hotmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To assess the effect of preoperative assessment clinic on prognosis and economic results of patients with coexisting diseases, the investigators designed a prospective cohort study. The investigators will recruit 250 patients preparing to undergo a selective epigastrium surgery with coexisting medical diseases which need an anesthetic consultation. The patients will be randomly assigned into two groups. The intervention group will be seen in the preoperative clinic before hospitalization, while the control group will get anesthetic consultation after hospitalization without clinic service. No additional interventions will be given during and after surgery. The length of stay, hospitalization expense, postoperative complication rate and mortality rate of the two groups will be compared. The investigator assume that consultation in preoperative assessment clinic will improve the prognosis and decrease the hospitalization expenses.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 250
Est. completion date June 30, 2022
Est. primary completion date January 31, 2022
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria:

- patients preparing to undergo a selective epigastrium surgery

- patients with coexisting medical diseases needing an anesthetic consultation

- over 60 years old

- ASA II-III

- patients with good compliance

Exclusion Criteria:

- patients ubdergoing emergency operation

- ASA I, IV

- patients under 60 years old

- patients with bad compliance

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
consultation in preoperative assessment clinic
The treatment group will be seen in the preoperative clinic before hospitalization, while the control group will get anesthetic consultation after hospitalization without clinic service. No additional interventions will be given during and after surgery.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

References & Publications (2)

Ferschl MB, Tung A, Sweitzer B, Huo D, Glick DB. Preoperative clinic visits reduce operating room cancellations and delays. Anesthesiology. 2005 Oct;103(4):855-9. — View Citation

van Klei WA, Moons KG, Rutten CL, Schuurhuis A, Knape JT, Kalkman CJ, Grobbee DE. The effect of outpatient preoperative evaluation of hospital inpatients on cancellation of surgery and length of hospital stay. Anesth Analg. 2002 Mar;94(3):644-9; table of — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other postoperative complication rate an average of 5 days
Other mortality rate an average of 5 days
Primary length of stay an average of 5 days
Secondary hospitalization expense The expense patients cost during hospitalization an average of 5 days
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